Anesthesia MorbidityNCT03028688
HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy
A study testing High flow nasal cannula oxygen in people with Anesthesia Morbidity, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Morbidity
- What is being tested?
- High flow nasal cannula oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2017to 9 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.
- Age greater than or equal to 18 years
Who cannot join
- Propofol, midazolam, or fentanyl allergy
- Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)
- Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: HIFLO ENDO- Use of High Flow Nasal Cannula Oxygenation to Increase Patient Safety During Upper GI Endoscopy
Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.
- Conditions
- Anesthesia Morbidity
- Being tested
- High flow nasal cannula oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula oxygenDevice
Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.
| Study group | Role | What they receive |
|---|---|---|
| Current standard of care | No intervention | Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed. |
| High flow nasal cannula group | Experimental | Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed. Receives: Device: High flow nasal cannula oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia event (Low blood oxygen level)
The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
Measured: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Secondary outcomes (2)
Hypercarbia event (Elevated blood CO2 level)
The secondary outcome measure will be occurrence of an elevated blood carbon dioxide level defined as 20 mmHg above the patient's baseline value at any time during their anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
Measured: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Hypotension event (Low blood pressure)
The secondary outcome measure will occurrence of low blood pressure defined as blood pressure 25% below baseline value any time during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
Measured: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start21 Jun 2017
- Primary completion9 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Responsible party
- Principal investigator, Michael Mazzeffi, University of Maryland, Baltimore
- Investigators
- Michael A Mazzeffi, MD MPH, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028688
- Sponsor's protocol ID
- HP-00071111
- Status last verified
- Jul 2022
- First submitted
- 11 Jan 2017
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.
PubMed 32398433
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIFLO ENDO- Use of High Flow Nasal Cannula Oxygenation to Increase Patient Safety During Upper GI Endoscopy
- ClinicalTrials.gov ID
- NCT03028688
- Acronym / sponsor ID
- HP-00071111
- Conditions
- Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current standard of care | No intervention | –Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed. |
| High flow nasal cannula group | Experimental | Device: High flow nasal cannula oxygenParticipants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.
- Age greater than or equal to 18 years
Key exclusion criteria (3 listed)
- Propofol, midazolam, or fentanyl allergy
- Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)
- Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannula oxygenParticipants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode. | Device | High flow nasal cannula group |
Primary outcome
Hypoxemia event (Low blood oxygen level)
Time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.
2 secondary outcomes
Hypercarbia event (Elevated blood CO2 level)
Time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Hypotension event (Low blood pressure)
Time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 32398433Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Mazzeffi, MD MPH principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula oxygen in people with Anesthesia Morbidity, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia event (Low blood oxygen level) (time frame: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03028688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.